Technology and innovations have come to the healthcare industry in a haphazard fashion. The unplanned development of medical technology has cluttered both the physical operating room (OR) landscape and the surgeon's and other healthcare team member's mental mindscape with a disjoint collection of equipment and instruments. Subsequently, the unplanned development has created many gaps in the surgery's potential capabilities as well as fragmentation of the environment which harbors inefficiency, invites human-error, and suffers preventable mishaps. The OR clutter has resulted as a consequence of fragmentary innovations without commitment to any unifying design philosophy or overarching physical and sensory infrastructure. Essentially, the principles of human modeling and simulation (HMS) and human factors engineering have been ignored, thereby allowing piecemeal innovation to box the surgeon and process into a corner. The development of future healthcare environment must integrate HMS engineering principles into and throughout the design process so that we can produce a generation of truly “smart” instruments that serve critical process needs and procedures as opposed to offering another batch of simply “clever” gadgets.
All industries seek to define and implement quality processes as many activities move from a cottage industry to mature scientific endeavor. Management tools such as Total Quality Management (TQM), Six Sigma, and ISO 9000, among others, are difficult to uniformly apply until the processes of an industry have evolved to the point of specific definition, standardization, measurement, and optimization. For an industry to effectively and rapidly ramp up to the quality standards demanded by the world market place, requires a smart environment that complements the human decision making and compensates for both human fallibilities and systems vulnerabilities. Health care is a traditional industry that straggles to meet the quality demands of the twenty first century: effectiveness, efficiency (economy) and safety.
As healthcare leadership examines the delivery of healthcare in America, a glaring deficit emerges: the lack of modem safety systems to reduce the iatrogenic injuries inflicted in the delivery of care. The physicians, nurses, and support staff are not careless, but rather the entire system is vulnerable. The Institutes of Medicine released a report in 2000, estimating that 3.7 percent of all hospitalizations are marred by an adverse event and forty-three percent of those adverse events occurred in surgery, a disproportionately high rate compared to all hospitalized patients.
Analysis of the events indicates that 70 percent of these events were preventable. A significant number of patient deaths are attributed to medical error, 44,000 to 98,000 per year. Regardless of which set of numbers is judged to be more accurate, expert opinion is that the rate of medical error, particularly surgical error, must be controlled.
An explosion of new technical surgical equipment and associated intricate surgical procedures has created a complex, high-risk environment for the modem surgeon. It harbors inefficiency as well as systemic vulnerability to error. Human errors lead to patient morbidity, mortality, and other adverse events. Many of the activities within the OR are disjointed. There is a need to organize the personnel around the central task in order to focus their intellectual and physical efforts. The operating room is plagued by poor acoustics and a surgical site that cannot be readily visualized by many members of the OR team. Therefore, the constructive oversight and suggestions of all team members cannot be accomplished because most of the team is simply “left out” of the procedure.
The disconnect between the anesthesiologist, circulating nurse and the hospital support network causes innumerable inefficiencies, distractions, and interpersonal tensions. Logistical demands of complex surgery, particularly endoscopic surgery, aggravate this situation within the OR, leading to miscommunications, non-communication, lack of efficient teamwork, and general failure of the OR personnel to form an effective team.
The OR has evolved into a complex human-machine system in which traditional means of communication and control are no longer satisfactory. Now the human actors, including surgeons, anesthesiologists, and nursing staff, require an overarching system to facilitate their interactions, minimize errors, and allow the surgeon to concentrate on the task at hand: actually performing the surgical procedure. Confusion and lack of situational awareness on the part of all the OR team members degrades both safety and efficiency.
With complex equipment, people, and purposes, it is easy to see where conflict and difficulty maintaining healthy team dynamics arise. Humans have limits; there is a point at which multitasking becomes over-tasking. Furthermore, the rigid hierarchy has proven in many circumstances to inhibit subordinates from giving clues and corrections to obvious mistakes of the surgeon or anesthesiologist who are generally placed at the top of the hierarchical system. There are time pressures, safety concerns and basic tensions as the various player roles and parallel activities come together. Research shows that surgeons as well as other team members would prefer a more collaborative environment with team input and direction.
By way of example, looking at the transfer of materials, the circulator and scrub nurse provide the flow of instruments, implants and expendable items for the operation. They also clear specimens, unneeded instruments, and used expendables to reduce clutter. The circulator also completes a great deal of documentation including: basic paperwork recording surgical events and exact procedures performed, who is in the room, surgery start time, specimens, drugs administered, and material requisition and billing sheets.
The circulator shuttles between instrument and material storage rooms within and outside of the OR to obtain needed materials for the procedure. Outside shuttling is also facilitated by the OR clerk and manager who communicate with the hospital logistics system, the laboratory, radiology, among others, to provide material support.
The OR team does not function in a vacuum. During the course of surgery there are many messages relayed to the surgeon, anesthesiologist, and other team members. Some of these messages are pertinent to the surgery. Many are pertinent to other medical business or even personal business.
Neither the problems nor solutions are superficial. The problems are deeply buried in the details of the surgical process and the activities within the OR. They require a solution with intense observation, thoughtful analysis, re-engineering of the OR, and appropriate training of the actors.
What is needed in the art is an OR with: more effective, efficient, and safer processes, including planning, surgical, and anesthesia processes that do the right things correctly, quickly, and using scarce resources sparingly, so as to cause no undue harm to the patient; more complete, accurate, and timely situation awareness, including shared team knowledge of the patient, equipment, materials and supplies, processes, and team activities; more effective logistics, including a more proactive support process that provides what is needed, where it is needed, when it is needed; better communication about the state of the OR system and processes, team goals, requests, and directives; and more complete, accurate, and timely documentation that not only meets accounting and archiving purposes, but produces records in real-time that are immediately useful to the OR team through a process that is less time consuming and disruptive to other OR activities.